OsteoporosisPhase 4NCT06264609
Precision Medicine Approach for Osteoporosis - Follow Up Study
A Phase 4 study testing Alendronate and Teriparatide in people with Osteoporosis, run by Paul F Netzel at 1 site in United States.
Trial summary
Osteoporosis is a health problem of major proportions. It affects more than 40 million Americans and results in more than 2 million fractures annually among Medicare patients alone. Hospital admissions for osteoporotic fractures exceed those of heart attacks, strokes and breast cancer combined. Read more about this study
- Who is it for?
- Ages 45 years and older, women only
- Conditions the study is for
- Osteoporosis
- What is being tested?
- Alendronate and Teriparatide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2024to 31 Dec 2029
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed Osteoporosis by DXA (BMD t-score = -2.5 with or without fragility fractures)
- Prior enrollment and completion of therapy in the "Novel precision medicine approach to treatment of osteoporosis based on bone turnover" trial.3) Premenopausal, menopausal, and post-menopausal females.
- 45 years old and older.
- Normal levels of Vitamin D
- Absence of all exclusion criteria on clinical workup. Patients diagnosed as osteoporotic due to the presence of
Who cannot join
- Pregnant or trying to become pregnant or are breastfeeding
- Use of systemic anticoagulation (blood thinner)
- Planned or anticipated oral surgery within the next 12 months
- Planning to move out of the area within 18 months of the study
- Inability to stand or sit upright for at least 30 minutes
- Chronic alcoholism and/or drug addiction
Show all 13Show fewer
- Prior radiation therapy (external beam or implant radiation) involving the skeleton (only if randomized to the bone forming drug (anabolic Forteo®))
- Systemic illnesses or organ diseases that may affect bone (except type 1 or type 2 diabetes mellitus)
- Clinical condition that may limit study participation (e.g., heart diseases (unstable angina), lung diseases (severe COPD), other infections)
- Abnormalities of the esophagus (tube connecting the mouth to the stomach) which delay esophageal emptying such as stricture (narrowing) or achalasia (a condition that prevents normal swallowing)
- Have other bone diseases that are not linked to age or menopause
- Have a history of malignancy (cancer), not including non-melanoma skin cancer.
- Vitamin D (Calcidiol) level below the normal range (below 20ng/mL).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Novel Precision Medicine Approach to Treatment of Osteoporosis Based on Bone Turnover - Follow Up Study
Osteoporosis is a health problem of major proportions. It affects more than 40 million Americans and results in more than 2 million fractures annually among Medicare patients alone. Hospital admissions for osteoporotic fractures exceed those of heart attacks, strokes and breast cancer combined. Osteoporosis is commonly considered a disease associated with menopause. This estrogen deficiency related bone loss is characterized by high bone turnover with increased resorption without commensurate changes in bone formation. It is in contrast to age-related bone loss, which starts as early as in the fourth decade of life and continues with increasing age. Age-related bone loss is usually associated with lower bone turnover and decreased bone formation is the main abnormality.
Current therapies do not address age-related bone loss and the special needs of the age-related osteoporosis population is currently ignored. This is to a great degree due to difficulties associated with the bone biopsy necessary for unequivocal determination of bone turnover status. Thus, the current standard of care relies on starting with an antiresorber, which is of limited effectiveness in age-related osteoporosis, and in fact impedes the effectiveness of the appropriate anabolic medication. In a current ongoing study - Novel precision medicine approach to treatment of osteoporosis based on bone turnover. EIRB#70781; efforts are focused on addressing this particular problem.
Our follow-up study seeks to achieve one specific aim: to compare effectiveness of Alendronate vs Teriparatide after participants have been switched at the end of treatment at year one, to the other drug at year two for the same duration of treatment.
Read the detailed description
This will be a prospective, longitudinal crossover trial for participants who have completed therapy in the main trial - Novel precision medicine approach to treatment of osteoporosis based on bone turnover. EIRB#70781.
Participants will be informed of the continuation / follow-up study at enrollment into the main trial. Participants will be approached for further participation in the continuation trial near the end of the initial 12 months treatment period. Consent will be obtained at the final visit of the main trial and crossover therapy will be initiated at that time.
Participants in Group 1 low turnover, who have received Teriparatide in the main trial and if it is determined that the participant did not respond well to therapy; will be assigned to Alendronate for 12 months. Participants in Group 2 low turnover who received Alendronate in the main trial and if it is determined that the participant did not respond well to therapy; will be assigned to Teriparatide for 12 months. Participants in Group 2 low turnover who received Alendronate in the main trial and if it is determined that the participant responded to therapy; will be continued on Alendronate for 12 months.
- Conditions
- Osteoporosis
- Being tested
- Alendronate, Teriparatide
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlendronateDrug
Also called Grp 1
Participants in Group 1 low turnover, who have received Teriparatide in the main trial and if it is determined that the participant did not respond well to therapy; will be assigned to Alendronate for 12 months.
TeriparatideDrug
Also called Grp 2
Participants in Group 2 low turnover who received Alendronate in the main trial and if it is determined that the participant did not respond well to therapy; will be assigned to Teriparatide for 12 months.
AlendronateDrug
Also called Grp 2c
Participants in Group 2 low turnover who received Alendronate in the main trial and if it is determined that the participant responded to therapy; will be continue on Alendronate for 12 months.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 Low Turnover - crossover | Experimental | Alendronate Receives: Drug: Alendronate |
| Group 2 Low Turnover - crossover | Experimental | Teriparatide Receives: Drug: Teriparatide |
| Group 2 Low Turnover - continuation | Experimental | Alendronate Receives: Drug: Alendronate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change in bone loss
The primary endpoint for the follow up study will be bone loss as determined by the percent change in DXA absolute values of the lumbar spine, femoral neck, total hip and radius measured at baseline, at the end of the one-year trial; and at end of the one year follow up study. DXA is chosen because of its wide availability, low radioactivity exposure, and clinical use.
Measured: 12 months
Secondary outcomes (1)
Percent change in Bone Mass Density at the hip
Secondary endpoints will be percent change in BMD at the hip measured at baseline, at the end of the one-year trial; and at end of the one year follow up study. DXA is chosen because of its wide availability, low radioactivity exposure, and clinical use.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start1 Feb 2024
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Paul F Netzel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Paul F Netzel, University of Kentucky
- Investigators
- Paul Netzel, DNP, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06264609
- Sponsor's protocol ID
- 91026
- Status last verified
- Mar 2026
- First submitted
- 9 Feb 2024
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Precision Medicine Approach to Treatment of Osteoporosis Based on Bone Turnover - Follow Up Study
- ClinicalTrials.gov ID
- NCT06264609
- Acronym / sponsor ID
- 91026
- Conditions
- Osteoporosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Paul F NetzelUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 20 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Osteoporosis is a health problem of major proportions. It affects more than 40 million Americans and results in more than 2 million fractures annually among Medicare patients alone. Hospital admissions for osteoporotic fractures exceed those of heart attacks, strokes and breast cancer combined. Osteoporosis is commonly considered a disease associated with menopause. This estrogen deficiency related bone loss is characterized by high bone turnover with increased resorption without commensurate changes in bone formation. It is in contrast to age-related bone loss, which starts as early as in the fourth decade of life and continues with increasing age. Age-related bone loss is usually associated with lower bone turnover and decreased bone formation is the main abnormality.
Current therapies do not address age-related bone loss and the special needs of the age-related osteoporosis population is currently ignored. This is to a great degree due to difficulties associated with the bone biopsy necessary for unequivocal determination of bone turnover status. Thus, the current standard of care relies on starting with an antiresorber, which is of limited effectiveness in age-related osteoporosis, and in fact impedes the effectiveness of the appropriate anabolic medication. In a current ongoing study - Novel precision medicine approach to treatment of osteoporosis based on bone turnover. EIRB#70781; efforts are focused on addressing this particular problem.
Our follow-up study seeks to achieve one specific aim: to compare effectiveness of Alendronate vs Teriparatide after participants have been switched at the end of treatment at year one, to the other drug at year two for the same duration of treatment.
Detailed description
This will be a prospective, longitudinal crossover trial for participants who have completed therapy in the main trial - Novel precision medicine approach to treatment of osteoporosis based on bone turnover. EIRB#70781.
Participants will be informed of the continuation / follow-up study at enrollment into the main trial. Participants will be approached for further participation in the continuation trial near the end of the initial 12 months treatment period. Consent will be obtained at the final visit of the main trial and crossover therapy will be initiated at that time.
Participants in Group 1 low turnover, who have received Teriparatide in the main trial and if it is determined that the participant did not respond well to therapy; will be assigned to Alendronate for 12 months. Participants in Group 2 low turnover who received Alendronate in the main trial and if it is determined that the participant did not respond well to therapy; will be assigned to Teriparatide for 12 months. Participants in Group 2 low turnover who received Alendronate in the main trial and if it is determined that the participant responded to therapy; will be continued on Alendronate for 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 Low Turnover - crossover | Experimental | Drug: AlendronateAlendronate |
| Group 2 Low Turnover - crossover | Experimental | Drug: TeriparatideTeriparatide |
| Group 2 Low Turnover - continuation | Experimental | Drug: AlendronateAlendronate |
Who may qualify
- Ages
- 45 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosed Osteoporosis by DXA (BMD t-score = -2.5 with or without fragility fractures)
- Prior enrollment and completion of therapy in the "Novel precision medicine approach to treatment of osteoporosis based on bone turnover" trial.3) Premenopausal, menopausal, and post-menopausal females.
- 45 years old and older.
- Normal levels of Vitamin D
- Absence of all exclusion criteria on clinical workup. Patients diagnosed as osteoporotic due to the presence of
Key exclusion criteria (13 listed)
- Pregnant or trying to become pregnant or are breastfeeding
- Use of systemic anticoagulation (blood thinner)
- Planned or anticipated oral surgery within the next 12 months
- Planning to move out of the area within 18 months of the study
- Inability to stand or sit upright for at least 30 minutes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AlendronateAlso: Grp 1Participants in Group 1 low turnover, who have received Teriparatide in the main trial and if it is determined that the participant did not respond well to therapy; will be assigned to Alendronate for 12 months. | Drug | Group 1 Low Turnover - crossover |
| TeriparatideAlso: Grp 2Participants in Group 2 low turnover who received Alendronate in the main trial and if it is determined that the participant did not respond well to therapy; will be assigned to Teriparatide for 12 months. | Drug | Group 2 Low Turnover - crossover |
| AlendronateAlso: Grp 2cParticipants in Group 2 low turnover who received Alendronate in the main trial and if it is determined that the participant responded to therapy; will be continue on Alendronate for 12 months. | Drug | Group 2 Low Turnover - continuation |
Primary outcome
Percent change in bone loss
Time frame: 12 months
The primary endpoint for the follow up study will be bone loss as determined by the percent change in DXA absolute values of the lumbar spine, femoral neck, total hip and radius measured at baseline, at the end of the one-year trial; and at end of the one year follow up study. DXA is chosen because of its wide availability, low radioactivity exposure, and clinical use.
1 secondary outcome
Percent change in Bone Mass Density at the hip
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Paul Netzel, DNP principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Alendronate and Teriparatide in people with Osteoporosis, run by Paul F Netzel at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent change in bone loss (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026; AzTrials last refreshed its copy on 6 Nov 2026.